最新CEP变更申请表 cepapplicationformforrevisionandrenewalofcepupdatedseptWord文档格式.docx

最新CEP变更申请表 cepapplicationformforrevisionandrenewalofcepupdatedseptWord文档格式.docx

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Dateofsubmission:

……./……/……

Formatofsubmission（selectoneonly）:

eCTDNeeSPDFPaper

1.GeneralInformation

1.1Dossiernumberandsubstance

CEP…………………………/[Substancename]…………………………

Subtitle（ifapplicable）.…………………………

Incaseofgroupedrevision（arevisionaffectingseveralCEPs）,pleaselistthedossiernumbersandsubstanceshere:

1.2Typeofapplication（Pleasetickoneboxonly）

Notification（mayincludeseveralchanges）

Minorrevision（mayincludeseveralchangesincludingnotifications）

Majorrevision（mayincludenotificationsandminorchanges）

Renewal（notificationsandminorchangesmaybeincluded）

Groupedrevision（severaldossiersaffected）

Transferofholdership

2.Namesandaddresses

2.1Intendedcertificateholder:

（N.B.forexceptionalcaseswheretheholderwillnotbethemanufacturerpleasereferto4.2）

Nameofthecompany*

Address*

Postcode*

Town*

Country*

Telephone*

Fax*

E-mail*

Nameofacontactpersonwithinthecompany（ifdifferentfrom2.2）

Fieldsmarked*aremandatory

2.2Contactpersonauthorisedforcommunicationonbehalfoftheintendedholder:

（ifdifferentfrommanufacturerpleaseprovideanauthorisationletter-seeAnnex1）:

Title*（Mrs,Mr,Dr）

Firstname*

Familyname*

Jobtitle/Department

Addressforcorrespondence*

2.3Manufacturingsite（s）:

detailednameandaddressofallsites°

involvedinthemanufactureofthissubstance（ifdifferentfromtheintendedholder,pleasealsoreferto4.2）

°

Allsitesinvolvedinthemanufactureoftheactivesubstancefromtheintroductionofstartingmaterial（s）,includingqualitycontrol/inprocesstestingsites,intermediatemanufacturers,milling,micronisationandsterilisationsitesshouldbelistedinseparateboxesandtheirroleshouldbespecified

Role*

Nameofthecompany*

GPS（WGS84）coordinatesofthesite*:

Latitude（SorN）andLongitude（EorW）expressedinDegreesMinutesSecondsto1decimalplace

（AlternativelyitcanbeexpressedinDegreestoatleast5decimalplacesorDegreesMinutestoatleast3decimalplaces）

mainentrance

ifnotmainentrance,specifytheplace:

DUNSnumber

ifnotmainentrance,specifytheplace

Fieldsmarked*aremandatory

3.SpecificInformation

Ticktheappropriatechange（s）

Notifications

Immediate

Annual

Implementationdate（annualnotifications）

Changeinthenameand/oraddressofthecertificateholderofthefinalsubstance*

-

Changeinthenameand/oraddressofthemanufacturingsiteorqualitycontrolsiteforthefinalsubstance*

Deletionofamanufacturerofintermediateorofamanufacturingorqualitycontroltestingsiteforthefinalsubstance

Changeinthenameand/oraddressofamanufacturerofanintermediateusedinthemanufactureofthefinalsubstance*

Changeoradditionofamanufacturerofastartingmaterialorintermediateusedinthemanufacturingprocessofthefinalsubstancewhentheproposedmanufacturerispartofthesamegroupasthecurrentlyapprovedmanufacturer

Changeoradditionofamanufacturingsite/workshopforthefinalsubstancewhentheproposedmanufacturerispartofthesamegroupasthecurrentlyapprovedmanufacturer*

Changestoqualitycontroltestingforanintermediateorforthefinalsubstance

Introductionofanewsiteofmicronisation*

Tighteningofthespecificationlimitsforthefinalsubstance

Minorchangestoatestprocedureforthefinalsubstance.Editorialchangestoamethoddescriptionannexedtoacertificateofsuitability

Additionofaspecificationparameterforthefinalsubstance

Changeinthecompositionoftheimmediatepackaging

Changeinthecompositionofthesecondarypackaging

Removal/reduct